What are the responsibilities and job description for the Data Review Specialist position at INCOG BioPharma Services?
The Data Review Specialist is responsible for reviewing and approving Quality Control documentation. This documentation includes all Quality Control (QC) Chemistry and Quality Control Microbiology data. The Specialist will work in coordination with the Quality Assurance Technical Manager to perform periodic walkthroughs of the Quality Control laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness.
Responsibilities
• Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry and QC Microbiology.
• Partner with Quality Control in the data analysis, and data review process.
• Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions.
• In co-ordination with QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
• Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
• Use technical skills and applied statistics to analyze and track laboratory investigations and to identify sources of variability and error in QC processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
Competencies
• Exemplifies excellent interpersonal skills and can develop productive working relationships with colleagues, customers, suppliers, and partners. Demonstrated ability to influence positive outcomes without direct reporting authority.
• Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.
• Thrives in a team environment but can work autonomously with strong self-management and organizational skills.
• Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
• Upholds customer-centric mindset.
Minimum Qualifications
• Bachelor’s Degree required; degree preferred to be in Science (Chemistry, Biology, or Biochemistry); advanced degree preferred.
• Minimum of 2 years of biopharma industry experience, with at least 1 year of hands-on experience with isolator-based aseptic manufacturing Quality required.
• High level of understanding and oversight of Quality Control testing processes in both QC Chemistry and QC Microbiology for aseptic manufacturing.
• Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Preferred Qualifications
• Experience with building processes and procedures.
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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